Products | UK Regulatory Outlook March 2024

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General/ digital products

UK

Legislation introduced to cut smoking and vaping 

Following its consultation on measures to create a smokefree generation and tackle youth vaping, the government has, on 20 March, introduced the new Tobacco and Vapes Bill into Parliament. The legislation will:

• make it an offence for anyone born on or after 1 January 2009 to be sold tobacco products;
• prohibit proxy sales in line with the change in age of sale legislation;
• include all tobacco products, herbal smoking products and cigarette papers, in scope; and
• require warning notices in retail premises to read “it is illegal to sell tobacco products to anyone born on or after 1 January 2009” when the smokefree legislation comes into effect.

Under the bill, regulations can be made to: restrict vape flavours; restrict how vapes are displayed in stores; restrict packaging and product presentation for vapes; and apply the restrictions to non-nicotine vapes and other consumer nicotine products such as nicotine pouches. See our Insight for more.

The minister of health has confirmed that Northern Ireland will be included in the proposed legislation, subject to the approval by the NI Assembly.

Draft regulations on banning the supply and sale of disposable vapes

The government's consultation response, as referenced above, also highlighted that legislation would be brought forward to ban the sale and supply of disposable vapes and the draft regulations were published on 11 March.

The regulations will prevent anyone from supplying disposable vapes in the course of a business, whether or not by way of sale. Scotland and Wales will also implement these regulations, but Northern Ireland is considering its next steps. The explanatory memorandum explains that: "The ban will be brought into force at least 6 months after the instrument has been introduced to ensure businesses have sufficient time to adapt and run-down stocks."

The regulations are set to enter into force on 1 April 2025 and businesses that place disposable vapes on the UK market should remain vigilant about this forthcoming regulatory change.

Webinars for using the UKCA and CE markings to place products on the market in GB and NI

The Department for Business and Trade has published a list of upcoming webinars on the UK’s approach to product marking and placing products on the market in Great Britain and Northern Ireland.

With the government's recent announcement that it intends to introduce legislation to indefinitely recognise the CE mark for products, we anticipate that these webinars will provide an update on when this legislation will be introduced and provide further details on the proposals. Businesses should sign up to attend these webinars so they are aware of the forthcoming changes and to take the an opportunity to ask questions.

EU

European Parliament formally adopts Product Liability Directive

The European Parliament, on 12 March, formally adopted the new Product Liability Directive.

As a reminder, changes under the new rules include consumers being able to seek compensation for medically recognised damage to psychological health and damage in the form of destroyed or corrupted data.

Businesses will need to ensure there is always a business in the EU (that is, a manufacturer, importer or authorised representative) that can be held liable for a product, even if the product was not purchased in the EU. Another change is that the liability period has been extended to 25 years in exceptional cases.

The Council now needs to adopt the directive formally, after which it will be published in the EU Official Journal. The new rules will apply to products placed on the market 24 months after entry into force.

Once the final text of the directive has been published, businesses should familiarise themselves with the new rules to understand the impact on them and what changes they may need to implement.

European Court of Justice overturns decision on accessibility of technical standards on toy safety

The technical "harmonised" standards which enable compliance with the product regulations applicable in the EU and UK have historically only been made available to public from commercial organisations at a cost. Access to these documents can be refused if disclosing them would undermine the protection of commercial interests, including intellectual property, unless there is an overriding public interest in disclosure.

In 2018, the European Commission refused a request for harmonised technical standards on toy safety to be made available to the public. This refusal was upheld by the General Court in 2021.

However, earlier this month, the European Court of Justice overturned this ruling. It found that there is an overriding public interest in disclosing the respective harmonised standards. This will have dramatic implications for standards bodies, as well as savings for manufacturers of products as they will no longer need to buy the standards.

European Parliament adopts position on new toy safety rules

The European Parliament has formally adopted its final position on the new toy safety regulation.

As detailed in the previous Regulatory Outlook, the Parliament's position includes a further ban on harmful chemicals (to include endocrine disruptors), the introduction of digital product passports for all toys sold in the EU, and ensures toys comply with other EU legislation such as the AI Act and the General Product Safety Regulation. The text constitutes Parliament’s position at first reading. The file will be followed up by the new Parliament after the European elections on 6-9 June.

While the legislation is still yet to be formally approved, businesses should start to familiarise themselves with the changes.

European Parliament formally adopt Cyber Resilience Act

The European Parliament has formally adopted its position on the Cyber Resilience Act. The Act seeks to introduce new cybersecurity requirements for products with digital elements to enhance their resilience against cyber threats and provide consumers with more information about the security of these products.

It introduces a large raft of requirements for manufacturers of products with digital feature on the market. These include: to report cyber vulnerabilities of components; documenting and updating cybersecurity risk assessments; determining the support period to reflect the length of time during which the product is expected to be in use and ensuring this support period is specified at the time the product is purchased; and to ensure each security update made available to users remains available for a minimum of 10 years after the product has been placed on the market.

The text will now need to be formally adopted by the Council. It is anticipated that the Council will also adopt the Act at its next meeting, having reached an informal agreement on the act in November 2023 (see our previous Regulatory Outlook). Once adopted by both institutions, it will be published in the Official Journal, after which it will enter into force 20 days later. The new rules will apply three years after the law enters into force, to give manufacturers sufficient time to adapt.

Political agreement reached on Forced Labour Products Regulation

Please see Modern Slavery.

Sustainable products

UK

Extended producer responsibility for packaging waste: reporting changes coming into force 1 April 2024

As detailed in last month's Regulatory Outlook, amending regulations have been made which amend the Packaging Waste (Data Reporting) (England) Regulations 2023.

The amending regulations amend the definition of "household packaging" to add an additional test and clarify that sellers must report packaging supplied to businesses. 

The regulations also impose reporting obligations on distributors that supply unfilled packaging to a large producer, which then supplies it to a small or non-obligated producer. Currently, no one is required to report this packaging and these amendments will place the obligation on the distributor. 

These changes come into effect on 1 April 2024 and the guidance on the data that must be reported has been updated in line with these changes.

Businesses that fall within the scope of the extended producer responsibility scheme should review these new regulations and updated guidance to determine if their obligations are affected and whether they need to report additional data.

The amending regulations also require the Environment Agency to publish a list of large producers which will be published on this guidance page in April 2024 and will be regularly updated.

In line with these upcoming changes, Defra has published new guidance for businesses on assessing household and non-household packaging under the extended producer responsibility for packaging. The guidance addresses how to assess packaging and what evidence businesses must collect and keep if they are reporting any primary or shipment packaging as non-household packaging.

UK government launch consultation on introduction of CBAM

Please see Environment.

EU

Provisional agreement reached on Packaging and Packaging Waste Regulation

On 4 March 2023, a provisional political agreement was reached on the Packaging and Packaging Waste Regulation (PPWR). Below are some of the takeaway points from the latest draft:

• From 1 January 2030, certain single use plastic packaging formats will be banned, such as packaging for unprocessed fresh fruit and vegetables, packaging for foods and beverages filled and consumed in cafés and restaurants, individual portions (for example condiments, sauces, creamer, sugar), accommodation miniature packaging for toiletry products and shrink-wrap for suitcases in airports.
• Ban on “forever chemicals” (PFAS) in food contact packaging. The agreed text outlines that this ban would come into force 18 months after the PPWR enters into force.
• Final distributors of beverages and take-away food in the food service sector would be obliged to offer consumers the option of bringing their own container. They would also be required to offer 10% of products in a reusable packaging format by 2030.
• Minimum recycled content targets for any plastic part of packaging.
• Minimum recycling targets by weight of packaging waste generated and increased recyclability requirements.
• Mandatory deposit return schemes – 90% of single use plastic and metal beverage containers (up to three litres) to be collected separately by 2029.
• Change to the definition for post-consumer recycled plastic.

The provisional agreement now needs to be formally adopted by both the Council of the EU and the European Parliament, after which it can be published in the EU’s Official Journal and enter into force. The regulation will be applied from 18 months after the date of entry into force. However, there have been recent reports of lobbying against the PPWR and so we anticipate that there could be some delays to the final votes. 

European Parliament adopts position on reducing textiles and food waste

The European Parliament has adopted its final proposal on reducing food and textile waste.

Its position, as set out in last month's Regulatory Outlook, agrees with the Commission's proposal to introduce extend producer responsibility (EPR) schemes for textiles, but states that Member States are required to establish these schemes within 18 months after the directive comes into force (compared to 30 months proposed by the Commission).

Additionally, the Parliament's position sets out higher waste reduction targets to be met at national level by 31 December 2030, including in food processing and manufacturing which are at least 20% (instead of 10% as proposed by the Commission). The file will be followed up by the new Parliament after the June elections, but businesses should start to understand the impact the new legislation may have on them.

Next steps for EU PFAS restriction proposal

The European Chemicals Agency (ECHA) has this month provided an update on the next steps for the proposal to restrict per- and polyfluoroalkyl substances (PFAS) (see our January Regulatory Outlook for more).

The ECHA's scientific committees for Risk Assessment and for Socio-Economic Analysis will evaluate the proposed restriction on the manufacture, placing on the market and use of PFAS alongside the comments received from the consultation, focusing on the different sectors that may be affected. In parallel, the five countries that prepared the proposal will also evaluate the consultation comments received and will update their initial report to address them. This updated report will be assessed by the committees and be the foundation for their opinions.

At the next committee meetings, which are scheduled for March, June and September 2024, the ECHA and committees will discuss specific sectors and elements of the proposal. More information on next procedural steps will be announced as work advances.

EU directive to empower consumers for the green transition published in the Official Journal of the EU

Please see Advertising and marketing.

Life Sciences and Healthcare

Consultation on proposed update to the statutory scheme to control the cost of branded health service medicines

The Department of Health and Social Care has launched a consultation on proposals to update the statutory scheme to control the cost of branded health service medicines. As detailed in the January Regulatory Outlook, the 2019 voluntary scheme for branded medicines pricing and access (VPAS) expired at the end of 2023, and has now been replaced by the new voluntary scheme for branded medicines, pricing, access and growth (VPAG). However, the government noted, when implementing VPAG, that further updates would need to be made to the statutory scheme for branded medicines and this latest consultation is in relation to those.

The consultation is proposing to introduce a differentiated approach to setting payment percentages for newer and older medicines:

• For newer medicines, setting a headline payment percentage of 11.6% in Q3 to Q4 2024, 14.1% in 2025 and 16.5% in 2026.
• For older medicines, setting a basic rate of 10.03% in Q3 to Q4 2024, 10.6% in 2025 and 11% in 2026, and a top-up rate of between 1% and 25%.
• Increasing the threshold for an exemption from scheme payments for small companies.
• Calculating the price decline of older medicines.

Pharmaceutical companies hoping to sell medicines to the UK NHS should review the consultation and decide whether it is worth responding. It closes on 26 April 2024.

MHRA publishes new guidance for assessment of established medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance outlining the process changes for "Established Medicines" which comes into effect on 1 March 2024. “Established Medicines” includes products that are not new active substances and line extensions to new active substances.

The key change to the assessment process is that the MHRA will carry out a technical completeness check of the application. This check will ensure that it has all necessary information to proceed with the assessment at the start of its review, which will enable it to assess applications more efficiently

The Veterinary Medicines (Amendment etc.) Regulations 2024

The draft Veterinary Medicines (Amendment etc.) Regulations 2024 have been published. These regulations have been made following the consultation response published last month (see previous Regulatory Outlook).

Changes made to the Veterinary Medicines Regulation 2013 include clarifying rules on advertising veterinary medicines, requiring additional information for an application for generic medicines to explain differences from the reference product, and requiring manufacturers to record more detail on the medicines they manufacture, to improve traceability.

CMA consults on proposal to launch a market investigation of the UK vet sector

Please see Consumer law.